Avedro, Inc., an ophthalmic pharmaceutical and medical device company and world leader in corneal remodeling, today announced that 50 commercial insurance plans now cover Avedros FDA-approved corneal cross-linking procedure, following Cignas recent announcement that it is covering the Photrexa drug formulations and the KXL System used in the treatment of progressive keratoconus. Other health plans recently initiating coverage include Humana, Blue Cross Blue Shield of Florida, Capital Blue Cross of Central Pennsylvania, Health Alliance Plan of Michigan, Blue Cross Blue Shield of Minnesota, Blue Cross Blue Shield of North Dakota and Priority Health of Michigan.
These recent positive decisions added nearly 35 million beneficiaries across all 50 states bringing the total number of covered lives to 133 million. Patients can find an updated list of plans with positive coverage policies at LivingwithKeratoconus.com.
In the past year, market access to FDA-approved corneal cross-linking has increased substantially. We have enjoyed collaborating with the ophthalmology societies and Avedro on this effort, said Mary Prudden, Director of the National Keratoconus Foundation. This encouraging progress will tremendously help patients who are struggling with progressive keratoconus, a sight-threatening disease.
In a continued effort to expand market access and reimbursement for cross-linking, Avedro also announced that Tim Homer joined the company as Vice President of Health Policy & Market Access. Mr. Homer will lead Avedros health policy, reimbursement and government relations activities.
Tim brings critical expertise to Avedro at an exciting time in our companys history, said Reza Zadno, PhD, CEO of Avedro. We are particularly pleased with the momentum we are seeing among commercial payers and CMS preliminary decision to grant a product-specific J code for our Photrexa drug formulations. Working closely with our executive leadership team, Tim will lead our efforts to broadly communicate the value of corneal cross-linking.
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Mr. Homers first initiative has been to expand ARCH (Avedros Reimbursement Customer Hub) services, including establishing a new field-based team to educate physician offices and payers and ultimately expand patient access to cross-linking.
Mr. Homer has more than 20 years of medical device and health policy experience. Previously, Mr. Homer worked at IRhythm as Vice President of Health Policy and Market Access where he was instrumental in helping grow revenue to more than $100M. Prior to IRhythm, Mr. Homer led global reimbursement and market access activities at HeartWare and additionally, worked in similar capacities at Boston Scientific and Johnson & Johnson.
Avedro is a privately held pharmaceutical and medical device company and the world leader in corneal remodeling. Our patented cross-linking technology, consisting of drug formulations and medical devices, are approved for sale in numerous countries around the globe. We continue to develop proprietary corneal remodeling products for the treatment of keratoconus, corneal ectasia and refractive correction as an alternative to contacts and eyeglasses. Keratoconus and corneal ectasia are rare and sight-threatening eye conditions in which the cornea progressively thins and weakens, causing the development of a cone-like bulge and optical irregularity of the cornea. At Avedro, our mission is to deliver to eyecare professionals around the world innovative, minimally invasive drugs and devices for corneal remodeling to improve patients vision and quality of life.
IMPORTANT SAFETY INFORMATION
INDICATIONS Photrexa Viscous (riboflavin 5-phosphate in 20% dextran ophthalmic solution) and Photrexa (riboflavin 5-phosphate ophthalmic solution) are indicated for use with the KXL System in corneal collagen cross-linking (CXL) for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.
LIMITATIONS OF USE The safety and effectiveness of CXL has not been established in pregnant women, women who are breastfeeding, patients who are less than 14 years of age and patients 65 years of age or older.
Photrexa Viscous and Photrexa should be used with the KXL System only.
WARNINGS AND PRECAUTIONS Ulcerative keratitis can occur. Patients should be monitored for resolution of epithelial defects.
ADVERSE REACTIONS In progressive keratoconus patients, the most common ocular adverse reactions in any CXL treated eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision. In corneal ectasia patients, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity, and blurred vision.
These are not all of the side effects of Photrexa Viscous, Photrexa and the CXL treatment. For more information, see Prescribing Information.
You may report an adverse event to Avedro by calling 1-844-528-3376, Option 1 or you may contact the U.S. Food and Drug Administration (FDA) directly at 1-800-FDA-1088.